BioCardia Inc. has completed a Pre-Submission to the U.S. Food and Drug Administration (FDA) under its Q-Submission program for the approval of its Helix Transendocardial Delivery Catheter. The Helix catheter is intended for intramyocardial therapeutic and diagnostic agent delivery to the heart. The submission is supported by data from fifteen well-controlled clinical trials across three primary cardiac clinical indications. The Pre-Submission was made under the CardiAMP Cell Therapy System FDA Breakthrough Designation. BioCardia is seeking to align with the FDA on the regulatory pathway and timing for approval, with a potential application for market clearance expected to follow.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. BioCardia Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 9651740) on February 10, 2026, and is solely responsible for the information contained therein.